Phase 1A/1B Study of SL-172154 in Subjects with Higher-Risk MDS or AML
Research type
Research Study
Full title
An Open-Label Phase 1a/1b Dose Escalation and Expansion Cohort Study of SL-172154 (SIRPα-Fc-CD40L) in Combination With Azacitidine or With Azacitidine and Venetoclax for the Treatment of Subjects With Higher-Risk Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML)
IRAS ID
1004472
Contact name
Vicki Horton
Contact email
Sponsor organisation
Shattuck Labs, Inc.
Eudract number
2021-003255-42
Clinicaltrials.gov Identifier
Research summary
This research study of a new study drug, referred to as SL-172154, is for the treatment of higher-risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukaemia (AML).
This study will test the safety and find the best dose of SL-172154 that can be given alone or in combination with azacitidine or azacitidine and venetoclax to participants with MDS or AML. SL-172154 is an immunotherapy drug. Immunotherapies are treatments that use your body's own immune (defence) system to help fight cancer.
Azacitidine is a medication that can help your bone marrow grow normal blood cells and kill abnormal blood cells that have grown too fast and do not work properly. Azacitidine is an approved medicine used for the treatment of adults with MDS and AML.
Venetoclax is an approved chemotherapy drug that works by helping to slow or stop the growth of cancer cells. Venetoclax in combination with azacitidine is an approved medicine for the treatment of adults with AML and is also currently being studied for the treatment of adults with MDS.
This is an open label study with two parts: dose escalation and dose expansion. Your study doctor will let you know which part you will be enrolled into. Dose escalation will determine the dose of SL-172154 expected to be safe and tolerable alone or in combination with azacitidine. Dose expansion will start once the dose escalation part is completed and the safe and tolerable dose of the SL-172154 in combination treatment is established.
The Sponsor of the study is Shattuck Labs, Inc. (Shattuck Labs). This study will include approximately 90 - 107 participants in total, from the USA, UK, Canada, and Spain.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
22/WM/0093
Date of REC Opinion
18 May 2022
REC opinion
Further Information Favourable Opinion